DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 5/28/2025. As directed by the amendment: claim(s) 1 and 11 have been amended. Thus, claims 1, 3, and 10-11 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 5/28/2025 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the preceding 112b rejection on page 5-6:
Applicant's present amendment resolves the preceding office actions stated 112b rejection of claim 1, 3, and 10-11.
Regarding applicant’s argument regarding the independent claims on page 7-8:
Applicant’s arguments with respect to claim(s) 1, 3, and 10-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 10-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 and 3,
Claim 1 and 3 recites “the protrusions” in multitude and specifically “the protrusion disposed to be closest to the handle among the plurality of protrusions”, however the claim simultaneously recites “a plurality of protrusions”, “a first protrusion”, “a second protrusion”, “one side protrusion”, “another side protrusion”, “2-1 protrusion”, and a “2-2 protrusion”, rendering the claim indefinite as it is unclear whether “the protrusions” and “the protrusion” are referring to the collective plurality of protrusions, both the first protrusion and the second protrusion, or only a specific first/second/other/another/2-1/2-2 protrusion. For examination purposes, the recitation of “the protrusions” is to be interpreted as “the plurality of protrusions” throughout the claims in view of paragraph 50-58 of applicant’s specification. For examination purposes the language of “the protrusion disposed to be closest to the handle among the plurality of protrusions” is to be interpreted as “a protrusion disposed” in view of applicant’s figure 4, which examiner notes that this specific protrusion is noted with numeral 322, referencing the claimed 2-2 protrusion.
Further regarding claim 1,
The claim refers to “wherein the protrusions are disposed only on the second part…wherein the first protrusion and the second protrusion each comprise one side protrusion and another side protrusion” and then proceeds to specify “wherein one side protrusion and another side protrusion of the first part are disposed to be symmetrical on the basis of the first part” which renders the claims indefinite as it is unclear whether another set of one side protrusion and the other side protrusion are being claimed as belonging to/being disposed on the first part raising concerns for a lack of antecedent basis of the protrusions, how a set of protrusions “of the first part” can be considered “of the first part” if they “are only disposed on the second part”, or if this is a typographical error and the claims are instead specifying that the previously recited one side protrusion and the other side protrusion of the first protrusion are disposed to be symmetrical on the basis of the first part. For examination purposes the claims are to be interpreted as “wherein one side protrusion and another side protrusion of the first protrusion are disposed to be symmetrical on the basis of the first part”, in light of applicant’s figure 10.
Further regarding claim 1,
The claim refer to a “first protrusion” and “second protrusion” in the singular form, however as is clear from the claim language of “wherein the first protrusion and the second protrusion each comprise one side protrusion and another side protrusion” and “wherein the second protrusion comprises a 2-1 protrusion and a 2-2 protrusion” further defining the claimed first protrusion and the claimed second protrusion, and in view of figures 3+7-10 of applicant’s disclosure, the claims are rendered indefinite as it is unclear whether the claims pertain to a singular first/second protrusion element which protrudes from the syringe body or is referring to a multitude of protrusions belong to unique groups of protrusions. For examination purposes the claims are to be interpreted as “…wherein the [plurality of] protrusions comprise a first protrusions and a second protrusions which are disposed to be spaced apart on the basis of the longitudinal direction of the plunger…” and “wherein the first protrusions and the second protrusions each comprise one side protrusions and another side protrusions” in light of paragraph 51-65 of applicant’s specification. The claimed first/second/one side/another side protrusion are to be pluralized throughout this claim and the dependent claims when recited.
Further regarding claims 1 and 10
The claims rely on the term “basis” to describe positional relationships of certain claim elements relative to other claim elements. The meaning(s) of the claim term “basis”, as provided by Merriam-Webster’s dictionary and as can be reasonably interpreted in light of applicant’s disclosure, may be “the bottom of something considered as its foundation”, “the principal component of something”, “something on which something else is established or based”, “the basic principle”, “a set of linearly independent vectors in a vector space such that any vector in the vector space can be expressed as a linear combination of them with appropriately chosen coefficients”. The specific uses of the claim term “basis” in the claim language of “wherein the first protrusion and the second protrusion each comprise one side protrusion and another side protrusion disposed in opposite directions on the basis of the first part”, “one side protrusion and another side protrusion of the first part are disposed to be symmetrical on the basis of the first part”, and “the one side protrusion of the first protrusion disposed on the top surface of the second part and the one side protrusion of the first protrusion disposed on the bottom surface of the second part are disposed to be symmetrical on the basis of the second part” render the claims indefinite as it is unclear what particular axis/axes/direction(s)/points on the claimed first part/second part are being considered the basis of those claim elements as they exist in three-dimensions with infinite aspects which can be considered the basis. In a limited example, the basis of the claimed first part could be considered its bottom relative to the longitudinal axis the plunger translates along, or the bottom when viewing the first part as it’s present in applicant’s figure 6 – which appears to be distinct from the bottom of the first part when viewing the invention as presented in applicant’s figure 5 –, or the basic principle of the first part could be considered its longest axis which extends parallel to the longitudinal direction the plunger translates along. For examination purposes the claims are to be interpreted as “wherein the first protrusion and the second protrusion each comprise one side protrusion and another side protrusion disposed in opposite directions on the basis of a radial axis of the first part”, “one side protrusion and another side protrusion of the first part are disposed to be symmetrical on the basis of a radial axis of the first part”, and “the one side protrusion of the first protrusion disposed on the top surface of the second part and the one side protrusion of the first protrusion disposed on the bottom surface of the second part are disposed to be symmetrical on the basis of- a radial axis of the second part”, in light of applicant’s figures 7-10. For the sake of clarity, examiner considers the radial axis of the first part to be the up/down axis of first part 211 when viewing applicant’s invention in the view presented in figure 7, the radial axis of the second part is considered to be the left/right axis of the second part 212 when viewing applicant’s invention in the view presented in figure 7, thus the radial direction is one which extends outward/inward relative to the intersectional center C of the first part 211 and second part 212.
Regarding Claims 3 and 10-11
Claims 3 and 10-11 are rejected for at least being dependent upon the rejected independent claim 1 and incorporating the same indefiniteness.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the protrusions are disposed only on the second part between the first part and the second part” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
See examiner’s annotation of applicant’s fig 8-10, below, denoting the manner in which applicant’s protrusions are considered to not be disposed only on the second part.
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 20110301496 A1, henceforth written as Lampropoulos, in view of US 20210008290 A1, henceforth written as Han, and in view of US 5685864 A henceforth written as Shanley.
Regarding Claim 1 ,
Lampropoulos discloses:
A medical syringe comprising:
(biopsy collection device 210; fig 5-8)
a cylinder
(claimed cylinder is considered to span syringe 236 from port 220 to its proximal flange (not enumerated) adjacent the plunger 238’s handle (not enumerated) ; fig 5-8)
comprising a stopper protruding inward;
(paragraph 29, “a stop member (not enumerated/illustrated) on the barrel of the syringe 236 projecting inwardly to selectively engage the spaced apart flanges along the stem of the plunger 238”)
and a plunger disposed inside the cylinder and moved back and forth in a first direction,
(plunger 238; fig 5-8)
wherein the plunger comprises a plurality of protrusions, wherein the plurality of protrusions is arranged at intervals along a longitudinal direction of the plunger,
(see examiner’s annotation of Lampropoulos’ fig 6 denoting the claimed plurality of protrusions and their disposal at intervals longitudinally)
wherein the stopper and any one of the plurality of protrusions selectively overlap on the basis of the first direction according to rotation of the plunger,
(paragraph 29)
wherein the plunger comprises a body on which the protrusions are arranged and a handle coupled to the body and disposed outside the cylinder,
(see examiner’s annotation of Lampropoulos’ fig 6 denoting the claimed body and handle)
wherein the body comprises a first part and a second part which are disposed to perpendicularly intersect each other to form a cross-shaped cross section, wherein the first part and the second part are planar plates,
(see examiner’s annotation of Lampropoulos’ fig 6 denoting the claimed first part and second part, as well as demonstrating their cross-shaping intersection and planar plate shape)
wherein the protrusions are arc-shaped plates and have a central angle which is an acute angle, wherein the protrusions are disposed only on the second part between the first part and the second part,
(see examiner’s annotation of Lampropoulos’ fig 6 denoting the claimed plurality of protrusions having an arc shape with an acute angle, as well as being disposed on only on the noted second part)
wherein the protrusions comprise a first protrusion and a second protrusion which are disposed to be spaced apart on the basis of the longitudinal direction of the plunger,
(see examiner’s annotation of Lampropoulos’ fig 6 denoting the claimed first protrusion, second protrusion, and their longitudinal spacing)
wherein the first protrusion is disposed to be closer to a sealing member of the plunger than the second protrusion,--
(fig 7-8 best illustrate the sealing member of the plunger 238 in the whole)
-- wherein a first groove is formed in the first part,
(see examiner’s annotation of Lampropoulos’ fig 6 denoting the claimed first groove)
wherein the first groove is configured to allow the stopper to pass through when the plunger rotates,
(paragraph 29)
wherein the first groove is disposed adjacent to the sealing member of the plunger,
(see examiner’s annotation of Lampropoulos’ fig 6 demonstrating the claimed first groove being disposed adjacent the claimed sealing member)
wherein a second groove is formed in the first part and the second part,
(see examiner’s annotation of Lampropoulos’ fig 6 denoting the claimed second groove and its formation in the first part and second part)
wherein the second groove is configured to allow the stopper to pass through when the plunger rotates within a range of 360°,
(paragraph 29 and examiner’s annotation of fig 6 demonstrate the rotatability of the stop member relative to the plunger via the claimed second groove)
wherein the second groove is disposed between the handle of the plunger and the protrusion disposed to be closest to the handle among the plurality of protrusions,
(see examiner’s annotation of Lampropoulos’ fig 6 denoting the claimed second groove and its disposition relative to the plurality of protrusions and plunger handle)
wherein the second protrusion comprises a 2-1 protrusion and a 2-2 protrusion, wherein the 2-1 protrusion is disposed to be close to the first protrusion rather than the 2- 2 protrusion, wherein a first distance between the first protrusion and the 2-1 protrusion is shorter than a second distance between the 2-1 protrusion and the 2-2 protrusion on the basis of the longitudinal direction of the plunger,
(see examiner’s annotation of Lampropoulos’ fig 6 denoting the claimed 2-1 protrusion, 2-2 protrusion, and their disposition relative to each other and other elements)
and wherein a negative pressure gauge is [provided when a clinician induces] a negative pressure inside a blood vessel.
(paragraph 28)
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Lampropoulos discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the first protrusion and the second protrusion each comprise one side protrusion and another side protrusion disposed in opposite directions on the basis of the first part,
and the one side protrusion and the other side protrusion are disposed to be rotationally symmetrical on the basis of an intersectional center of the first part and the second part
wherein one side protrusion and another side protrusion of the first part are disposed to be symmetrical on the basis of the first part,
Notably, MPEP 2144.04(VI)(B) provides that a modification of the prior art amounting to a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Accordingly, duplicating the first protrusion and the second protrusion of Lampropoulos, and their mating stop member, such that there are two sets of first protrusions and second protrusions on one side and another side of Lampropoulos for mating with opposingly disposed stop members would similarly lack patentable significance as a new and unexpected result is not produced by such a modification.
Further, Han teaches a suction syringe with plunger travel governing protrusions:
wherein the first protrusion and the second protrusion each comprise one side protrusion and another side protrusion disposed in opposite directions on the basis of the first part, and the one side protrusion and the other side protrusion are disposed to be rotationally symmetrical on the basis of an intersectional center of the first part and the second part, wherein one side protrusion and another side protrusion of the first part are disposed to be symmetrical on the basis of the first part,
(paragraph 57+60-62+72-74; the second embodiment of Han, shown in figs 8-11, demonstrate that holding plates 310, which govern plunger tr4avel by mating with clip 320, are disposed in each of spaces opposite to each other of the spaces between the partition walls of the plunger having a cross-shaped structure, see examiner’s annotation of fig 8 noting opposingly disposed plates for clarity, such that they are rotationally symmetrical about the axis aligned with the intersection of partition walls 210)
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Han’s teachings of opposingly and symmetrically disposed columns of protrusions for interfacing with a plunger travel stopping element by duplicating the plurality of protrusions and their mating stopper of Lampropoulos, and arranging Lampropoulos’ duplicated components in the opposing and symmetrical manner taught by Han and thus arriving at the claimed invention, in order to advantageously arrive at a modified invention with the ordinary and expected result of a plunger travel governing mechanism with a multitude of redundant mechanisms which consequently enhance the reliability of the invention in governing plunger travel in case manufacturing deficiencies, excessive use, or other failure modes result in one of the protrusions or stoppers performing its plunger travel governing function deficiently.
Lampropoulos in view of Han teaches the elements of the present claim, as described above. Yet, its present embodiment is silent on:
and wherein a negative pressure gauge is disposed in the cylinder to measure a negative pressure inside a blood vessel.
Notably, Lampropoulos discloses in paragraph 28, that a negative gauge pressure is provided when clinician draws blood from a patient, however Lampropoulos is silent and does not illustrate a specific structure for providing this pressure gauge quantity.
However Shanley teaches a syringe with a plunger travel governing mechanism comprising:
a negative pressure gauge is disposed in the cylinder to measure a negative pressure inside a blood vessel
(col 7 line 8-20; pressure gauge 32 is disposed in the fluid conveying aspects of the syringe invention, spanning barrel 12 and the distal port (not enumerated), to measure the negative plunger pressure inside the invention, and thus also inside the blood vessel of the patient as the negative plunger pressure is applied to the blood vessel to draw fluid from the body,
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Shanley into the modified invention of Lampropoulos in view of Han in order to advantageously arrive at an invention which can provide a quantitative measure of negative pressure to a clinician and therein improve the accuracy of the invention when the clinician intends to apply negative pressure to withdraw fluid from a patient, see col 7 line 8-20 of Shanley.
Regarding claim 3, Lampropoulos in view of Han and Shanely discloses:
The medical syringe of claim 1, wherein the body comprises a path on which the protrusions are not arranged when viewed in the longitudinal direction of the plunger.
Lampropoulos: ( see examiner’s annotation of Lampropoulos’ fig 8 denoting the claimed path)
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Regarding claim 10, Lampropoulos in view of Han and Shanely teaches:
The medical syringe of claim 1, wherein the one side protrusion of the first protrusion is disposed to protrude from each of a top surface and a bottom surface of the second part, and the one side protrusion of the first protrusion disposed on the top surface of the second part and the one side protrusion of the first protrusion disposed on the bottom surface of the second part are disposed to be symmetrical on the basis of the second part.
Examiner notes that in light of the modification of Lampropoulos in view of Han above, the first protrusion is provided with a one side protrusion and another side protrusion which are disposed on the surfaces of the claimed second part in the claimed opposing and symmetrical manner.
Regarding claim 11, Lampropoulos in view of Han and Shanely teaches:
The medical syringe of claim 1, wherein one side protrusion of the second protrusion is disposed on the top surface of the second part, and another side protrusion of the second protrusion is disposed on the bottom surface of the second part.
Examiner notes that in light of the modification of Lampropoulos in view of Han above, the second protrusion is provided with a one side protrusion and another side protrusion which are disposed on the surfaces of the claimed second part in the claimed opposing manner.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly the independent claims:
US 20130204130 A1
US 20180015227 A1
US 20110190709 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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